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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM,DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDexcom, Inc.
6340 Sequence Dr.
San Diego, CA 92121
PMA NumberP120005
Supplement NumberS042
Date Received11/24/2015
Decision Date02/05/2016
Withdrawal Date03/20/2026
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications to the attachment method that secures the disposable housing to the adhesive patch of the sensor pod of the G4 PLATINUM/G5 Mobile sensor component which required modifications to the disposable housing, implementation of a semi-automated heat staking machine and a change to the inspection method. The proposed change occurs at Tech Group, Dexcom’s approved supplier. The sensor is a component of the Dexcom G4 Platinum and Dexcom G5 Mobile Continuous Glucose Monitoring Systems.
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